MORF-057 is a selective, oral small molecule inhibitor of the α4β7 integrin in development to treat patients suffering from inflammatory bowel disease (IBD) that is currently in phase 2 studies.
α4β7 has been validated as a target for the treatment of IBD by the success of the approved injectable (infused) antibody therapeutic vedolizumab. MORF-057, like vedolizumab, is designed to block the interactions between α4β7 on the surface of predominantly T-cells circulating in the bloodstream and the mucosal vascular addressin cell adhesion molecule 1, MAdCAM-1, substantially reducing lymphocyte migration from the bloodstream into intestinal mucosal tissues and avoiding inflammation that is associated with IBD. Our initial focus is on ulcerative colitis, one of the most common forms of IBD, with plans to investigate MORF-057 in Crohn’s disease with potential other gastrointestinal diseases to follow.
Phase 1 clinical studies of MORF-057 demonstrated a favorable safety and pharmacokinetic profile.
Notably, α4β7 receptor occupancy greater than 99% was observed in multiple dose cohorts, exceeding pre-specified targets. Further, a series of preclinical results strongly support MORF-057 as a potential oral approach to α4β7 inhibition with results demonstrating similar activity and mechanistic patterns to vedolizumab.
Based on these results, Morphic is now conducting the phase 2 EMERALD program to evaluate MORF-057 in patients with moderate to severe ulcerative colitis. EMERALD-1, an open label phase 2a study of MORF-057 is currently enrolling patients and EMERALD-2, a global, randomized, controlled phase 2b study of MORF-057 is planned to begin in 2022.
For more information on the EMERALD clinical trials please click here.